Zinc as an Adjunctive Therapy for Cervical Dystonia

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07140874
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cervical Dystonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Zinc citrate — DRUG
    Oral zinc citrate 30 mg daily
  • Placebo — DRUG
    Placebo

Study Details

The goal of this clinical trial is to evaluate if supplemental zinc can prolong the duration of benefit of botulinum toxin injections in cervical dystonia patients receiving care at the University of Florida. The main aims are: 1. To evaluate the efficacy of zinc citrate supplementation in prolonging the duration of symptom relief provided by botulinum toxin type A (Botox) injections in cervical dystonia patients. 2. To assess the safety and tolerability of zinc supplementation in this patient population. 3. To analyze the potential influence of zinc supplementation on the quality of life and functional outcomes in cervical dystonia patients receiving Botox. Researchers will compare zinc citrate to a placebo (a look-alike substance that contains no active drug) to see if zinc works to extend the effects of Botox. Participants will: Take zinc citrate or a placebo every day for 3 months, then cross over to the alternative treatment for another 3 months. Visit the clinic every 3 months for Botox injections, check ups and surveys.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Zinc first
    Encapsulated zinc citrate 30 mg orally daily for 3 months followed by placebo capsule matching zinc daily for 3 months
  • Experimental: Placebo first
    Placebo capsule matching zinc daily for 3 months, followed by encapsulated zinc citrate 30 mg orally daily for 3 months

Primary Outcome Measure

Duration of Botox efficacy [ Time Frame: 3 and 6 months post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Norman Fixel Institute for Neurological DiseasesGainesvilleFlorida32608
Lauren Fanty, MD (PRINCIPAL_INVESTIGATOR)
Anastasia Barnes, MD (SUB_INVESTIGATOR)
Jerry Fenn, MD, PhD (SUB_INVESTIGATOR)
Pooja Gupta, MD (SUB_INVESTIGATOR)
Matthew Remz, MD (SUB_INVESTIGATOR)
Jun Yu, MD (SUB_INVESTIGATOR)
Irene Malaty, MD (SUB_INVESTIGATOR)

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Norman Fixel Institute for Neurological Diseases· Gainesville, FL

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